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Medical Devices
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Standards Organizations
FDA and the medical device regulatory agencies of other countries are utilizing consensus standards from a variety of organizations. For information about FDA's use of Standards, please see the CDRH Standards Program site.
| A resource for national and international standards | |
| A private, nonprofit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment system. | |
| A non-for-profit organization that provides a global forum for the development and publication of voluntary consensus standards for materials, products, systems, and services. | |
| A global organization that prepares and publishes international standards for all electrical, electronic, and related technologies. | |
| The European Committee for Electrotechnical Standardization | |
| A worldwide federation of national standard bodies from 140+ countries | |
| A nonprofit standards developing and educational organization. NCCLS was formerly known as National Committee for Clinical Laboratory Standards. It is now a global organization and develops consensus documents for additional audiences beyond the clinical laboratory community. | |
| National Center for Standards and Certification Information (NCSCI). Provides information on U.S., foreign, and international voluntary standards; government regulations; and rules of conformity assessment for non-agricultural products. The Center serves as a referral service and focal point in the U.S. for information about standards and standards related information. It also provides information regarding Technical Barriers to Trade (TBT) | |
| Publishes officially recognized standards for the use of medicines and other health care technologies |
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